GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000

GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000 is an FDA 510(k)-cleared medical device (K032085) manufactured by Nidek, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 2, 2003. Regulation: 8.